Global and organ-specific response according to center evaluation (response based on Couriel criteria), NIH response criteria, and changes in NIH severity score (NIH SS)
| Center (Couriel) . | NIH criteria . | Changes in NIH SS . | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Response . | Overall . | Response . | Skin . | Lungs . | Mouth . | Liver . | Gut . | Overall . | Response . | Skin . | Lungs . | Mouth . | Liver . | Gut . | Overall . |
| ORR corr* | 46% | ORR corr* | 51.3% | ORR corr* | 56.4% | ||||||||||
| ORR | 36% | ORR | 32% | 35% | 16% | 25% | 50% | 51.3% | ORR | 22% | 25% | 38% | 25% | 50% | 51.3% |
| CR | 0 | CR | 3 | 2 | 4 | 2 | 5 | 0 | CR | 3 | 2 | 4 | 2 | 5 | 0 |
| PR | 14 | PR | 7 | 9 | 0 | 0 | 1 | 20 | PR | 4 | 6 | 5 | 0 | 0 | 20 |
| MR/SD | 12 | SD | 15 | 13 | 18 | 4 | 4 | 7 | SD | 20 | 17 | 13 | 5 | 3 | 9 |
| NR/PD | 5 | PD | 2 | 1 | 0 | 0 | 2 | 5 | PD | 0 | 1 | 0 | 0 | 2 | 3 |
| NE | 8 | NE | 4 | 7 | 3 | 2 | 0 | 7 | NE | 4 | 6 | 2 | 1 | 0 | 7 |
| TOT. | 39 | TOT | 31 | 32 | 25 | 8 | 12 | 39 | TOT | 31 | 32 | 24 | 8 | 10 | 39 |
| EVAL | 31 | EVAL | 27 | 25 | 22 | 6 | 12 | 32 | EVAL | 27 | 26 | 22 | 7 | 10 | 32 |
| Center (Couriel) . | NIH criteria . | Changes in NIH SS . | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Response . | Overall . | Response . | Skin . | Lungs . | Mouth . | Liver . | Gut . | Overall . | Response . | Skin . | Lungs . | Mouth . | Liver . | Gut . | Overall . |
| ORR corr* | 46% | ORR corr* | 51.3% | ORR corr* | 56.4% | ||||||||||
| ORR | 36% | ORR | 32% | 35% | 16% | 25% | 50% | 51.3% | ORR | 22% | 25% | 38% | 25% | 50% | 51.3% |
| CR | 0 | CR | 3 | 2 | 4 | 2 | 5 | 0 | CR | 3 | 2 | 4 | 2 | 5 | 0 |
| PR | 14 | PR | 7 | 9 | 0 | 0 | 1 | 20 | PR | 4 | 6 | 5 | 0 | 0 | 20 |
| MR/SD | 12 | SD | 15 | 13 | 18 | 4 | 4 | 7 | SD | 20 | 17 | 13 | 5 | 3 | 9 |
| NR/PD | 5 | PD | 2 | 1 | 0 | 0 | 2 | 5 | PD | 0 | 1 | 0 | 0 | 2 | 3 |
| NE | 8 | NE | 4 | 7 | 3 | 2 | 0 | 7 | NE | 4 | 6 | 2 | 1 | 0 | 7 |
| TOT. | 39 | TOT | 31 | 32 | 25 | 8 | 12 | 39 | TOT | 31 | 32 | 24 | 8 | 10 | 39 |
| EVAL | 31 | EVAL | 27 | 25 | 22 | 6 | 12 | 32 | EVAL | 27 | 26 | 22 | 7 | 10 | 32 |
ORR, overall response rate, calculated as (CR + PR)/TOT (total number of patients receiving imatinib); ORR corr*, corrected ORR, taking into account patients with MR/SD with concomitant steroid sparing (>50% of the initial dose); CR, complete response; PR, partial response; MR, minor response; SD, stable disease; NR, no response; PD, progressive disease; NE, not evaluable (NE category includes patients who did not undergo a CR evaluation at 6 months because of treatment failure within 6 months [7] or other reasons [1 for Center Response]); TOT, total patients receiving imatinib included in the ITT analysis; EVAL, includes patients undergoing a complete response evaluation at 6 months according to NIH, Center, and changes in NIH SS response.
According to Center (Couriel) criteria, patients with SD and without significant steroid-sparing were considered NR; in the category MR/SD, we included patients with SD and >50% steroid reduction, and all patients with MR.22